IT Validation Concept

The range of GMP-relevant, computer-aided systems that require validation is huge. It extends from PLC-controlled machines and microprocessor-controlled small devices to process control systems and company-wide information systems such as ERP or document management systems. Guidelines issued by authorities and specialised organisations, above all the GAMP guideline, define important concepts and fundamental approaches. But they are too abstract except for specialists, and cannot be implemented without experience – or only at a high cost and risk.

The challenge is to develop and implement a functioning, practical concept, a structured IT validation process. Defined in an SOP that is optimally integrated into existing business processes.

Introduction to the Topic as a First Step Towards Successful Validation

A uniform awareness of the topic and understanding of the fundamental requirements are important for the successful implementation of an IT validation concept. That is why gempex at the outset of such projects recommends introducing the topic in the course of in-house training and expanding existing knowledge. This leads to the integration of all stakeholders and raises awareness for the relevance of the task. Partners are gained.    

Concept Development – Standard Procedure Defined by SOP

The existing quality assurance system is analysed in regards to the validation of computer-aided systems with the help of the customer. On this basis, gempex develops a concept individually tailored to the organisation and specific processes. Here gempex uses proven standard building blocks and templates that are adapted to the respective company.

This results in a clear, practical process description in the form of a concept SOP with all required attachments such as:  

  • planning and reporting templates
  • templates for system specifications such as the user requirement specification (URS)
  • templates for the supplier evaluation, for instance a checklist for on-site audits
  • risk analysis templates
  • inspection record templates (IQ/ OQ/ PQ).

These documents contain numerous, easy to understand processing notes and are perfectly prepared for practical use. All relevant regulatory requirements and current good practice concepts, especially according to the GAMP guideline, are integrated. 

Implementing Concepts, Preparing a Reliable Realisation

Once the approach has been defined and all tools have been prepared and delivered, only the implementation of the IT validation concept is missing. Ideally this once again starts in the form of training for the employees later involved in validation. Clearly and comprehensibly explaining the desired approach and use of the templates that were developed is essential here. Then the implementation can proceed reliably using these tools. And the results are traceable and compliant.   


  • guided, facilitated introduction to the topic
  • company-specific defined concept
  • integration into existing quality assurance systems
  • concept SOP with all required elements and templates
  • efficiency through the use of proven templates as a basis  
  • professional support with concept implementation
  • approach that meets legal requirements according to state-of-the-art science and technology